Spots Global Cancer Trial Database for Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
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Trial Identification
Brief Title: Sacituzumab Tirumotecan (MK-2870) in Post Platinum and Post Immunotherapy Endometrial Cancer (MK-2870-005)
Official Title: A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician's Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy (MK-2870-005/ENGOT-en23/GOG-3095)
Study ID: NCT06132958
Conditions
Study Description
Brief Summary: The primary objectives of this study are to compare sacituzumab tirumotecan to Treatment of Physician's Choice (TPC) with respect to progression-free survival (PFS) per response evaluation criteria in solid tumors (RECIST 1.1), as assessed by blinded independent central review (BICR), and overall survival (OS). The primary hypotheses are that sacituzumab tirumotecan is superior to TPC with respect to PFS per RECIST 1.1, as assessed by BICR, and that sacituzumab tirumotecan is superior to TPC with respect to OS.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
USA Mitchell Cancer Institute ( Site 4142), Mobile, Alabama, United States
Yale-New Haven Hospital-Smilow Cancer Hospital at Yale-New Haven ( Site 4114), New Haven, Connecticut, United States
MedStar Washington Hospital Center ( Site 4108), Washington, District of Columbia, United States
Mount Sinai Cancer Center ( Site 4117), Miami Beach, Florida, United States
Centricity Research Columbus Cancer Center ( Site 4154), Columbus, Georgia, United States
NorthShore University HealthSystem - Evanston Hospital ( Site 4110), Evanston, Illinois, United States
Parkview Research Center at Parkview Regional Medical Center ( Site 4132), Fort Wayne, Indiana, United States
TRIALS 365 ( Site 4105), Shreveport, Louisiana, United States
Washington University School of Medicine-Obstetrics & Gynecology ( Site 4146), Saint Louis, Missouri, United States
The Center of Hope ( Site 4109), Reno, Nevada, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 4156), Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 4106), New York, New York, United States
Duke Cancer Institute ( Site 4120), Durham, North Carolina, United States
The West Clinic, PLLC dba West Cancer Center ( Site 4102), Germantown, Tennessee, United States
Houston Methodist Hospital-Obstetrics and Gynecology ( Site 4130), Houston, Texas, United States
Hospital Británico de Buenos Aires-Oncology ( Site 1002), Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Aleman-Oncology ( Site 1001), Buenos Aires, Caba, Argentina
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1008), Buenos Aires, Caba, Argentina
Instituto Alexander Fleming-Alexander Fleming ( Site 1007), Ciudad Autónoma de Buenos Aires, Caba, Argentina
Centro de Educación Médica e Investigaciones Clínicas (CEMIC) ( Site 1004), Buenos Aires, , Argentina
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 1006), La Rioja, , Argentina
Blacktown Hospital ( Site 1101), Blacktown, New South Wales, Australia
GenesisCare North Shore ( Site 1103), St Leonards, New South Wales, Australia
Royal Brisbane and Women's Hospital ( Site 1102), Brisbane, Queensland, Australia
Epworth Freemasons ( Site 1104), East Melbourne, Victoria, Australia
Frankston Hospital ( Site 1105), Frankston, Victoria, Australia
Medizinische Universitaet Innsbruck-Univ.-Klinik f. Gynäkologie und Geburtshilfe ( Site 1201), Innsbruck, Tirol, Austria
AZ Maria Middelares-IKG ( Site 1305), Gent, Oost-Vlaanderen, Belgium
UZ Leuven-Gynecologic Oncology ( Site 1301), Leuven, Vlaams-Brabant, Belgium
CHU UCL Namur/Site Sainte Elisabeth-Trial Office ( Site 1304), Namur, , Belgium
Centre Hospitalier de l'Université de Montréal ( Site 1403), Montréal, Quebec, Canada
McGill University Health Centre ( Site 1404), Montréal, Quebec, Canada
James Lind Centro de Investigación del Cáncer ( Site 1504), Temuco, Araucania, Chile
Centro de Estudios Clínicos SAGA-CECSAGA ( Site 1505), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 1503), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 1501), Santiago, Region M. De Santiago, Chile
Fakultni nemocnice Ostrava-Gynekologicko-porodnicka klinika ( Site 1703), Ostrava, Moravskoslezsky Kraj, Czechia
Nemocnice AGEL Novy Jicin a.s.-Oddeleni radioterapie a onkologie ( Site 1706), Nový Jiín, Novy Jicin, Czechia
Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1702), Olomouc, Olomoucky Kraj, Czechia
Fakultni nemocnice Bulovka-Gynekologicko-porodnicka klinika ( Site 1701), Praha, Praha 8, Czechia
Rigshospitalet-Dept. of Oncology ( Site 1803), Copenhagen, Hovedstaden, Denmark
Aarhus Universitetshospital, Skejby ( Site 1802), Aarhus, Midtjylland, Denmark
Tampereen yliopistollinen sairaala ( Site 1901), Tampere, Pirkanmaa, Finland
Kuopion Yliopistollinen Sairaala ( Site 1904), Kuopio, Pohjois-Savo, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 1902), Helsinki, Uusimaa, Finland
Turku University Hospital-Department of Obstetrics and Gynecology ( Site 1903), Turku, Varsinais-Suomi, Finland
ROC37 ( Site 2010), Chambray Les Tours, Centre, France
Hôpital Privé Des Côtes d'Armor ( Site 2001), Plérin, Cotes-d Armor, France
CHU Besançon ( Site 2009), Besançon, Doubs, France
Institut Régional du Cancer Montpellier ( Site 2008), Montpellier, Herault, France
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 2003), Rennes, Ille-et-Vilaine, France
Centre Oscar Lambret ( Site 2007), Lille, Nord-Pas-de-Calais, France
CENTRE LEON BERARD ( Site 2004), Lyon Cedex08, Rhone-Alpes, France
Groupe Hospitalier Diaconesses Croix Saint Simon ( Site 2005), Paris, , France
Metropolitan Hospital-2nd Oncology Dept ( Site 2202), Athens, Attiki, Greece
Rambam Health Care Campus-Gyneco-oncology unit ( Site 2502), Haifa, , Israel
Edith Wolfson Medical Center ( Site 2501), Holon, , Israel
Shaare Zedek Medical Center ( Site 2503), Jerusalem, , Israel
Rabin Medical Center ( Site 2505), Petah Tikva, , Israel
Sheba Medical Center ( Site 2504), Ramat Gan, , Israel
Sourasky Medical Center ( Site 2506), Tel Aviv, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Ginecologia Oncologica ( Site 2601), Roma, Lazio, Italy
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 2610), Rozzano, Milano, Italy
Azienda Ospedaliera Spedali Civili di Brescia-Obstetrics anf gynecology ( Site 2611), Brescia, , Italy
Istituto Europeo di Oncologia IRCCS ( Site 2607), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Oncologia Sperimentale Uro-Genitale ( Site 2, Napoli, , Italy
Ospedale Mauriziano-Ginecologia e Ostetricia ( Site 2608), Torino, , Italy
Seoul National University Bundang Hospital-Obstetrics and Gynecology ( Site 3505), Seongnam, Kyonggi-do, Korea, Republic of
Seoul National University Hospital ( Site 3502), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Gynecologic cancer center ( Site 3503), Seoul, , Korea, Republic of
Asan Medical Center-Division of Gynecologic Oncology, Dept. of Obstetrics & Gynecology ( Site 3501), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 3504), Seoul, , Korea, Republic of
Pantai Hospital Kuala Lumpur-Cancer Centre ( Site 2803), Kuala Lumpur, , Malaysia
Leids Universitair Medisch Centrum-Medical Oncology ( Site 3002), Leiden, Zuid-Holland, Netherlands
Stavanger Universitetssykehus ( Site 3103), Stavanger, Rogaland, Norway
Universitetssykehuset Nord-Norge HF ( Site 3101), Tromsø, Troms, Norway
Sorlandet Sykehus Kristiansand ( Site 3104), Kristiansand, Vest-Agder, Norway
Oslo universitetssykehus, Radiumhospitalet ( Site 3102), Oslo, , Norway
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 3201), Siedlce, Mazowieckie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Ginekologii Onkologicznej ( Sit, Warszawa, Mazowieckie, Poland
Bialostockie Centrum Onkologii-Oddzial Onkologii Ginekologicznej ( Site 3204), Bialystok, Podlaskie, Poland
Wielkopolskie Centrum Onkologii im. Marii Skłodowskiej-Curie-Oddział Radioterapii i Onkologii Ginek, Poznan, Wielkopolskie, Poland
Ad-Vance Medical Research-Research ( Site 3302), Ponce, , Puerto Rico
Pan American Center for Oncology Trials - Ciudadela ( Site 3301), San Juan, , Puerto Rico
UPR Comprehensive Cancer Center-Comprehensive Cancer Center Hospital ( Site 3304), San Juan, , Puerto Rico
National Cancer Centre Singapore-Medical Oncology ( Site 3401), Singapore, Central Singapore, Singapore
Hospital Universitario Reina Sofia-Oncologia Medica ( Site 3601), Cordoba, Andalucia, Spain
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 3608), Hospitalet, Barcelona, Spain
Clinica Universidad de Navarra ( Site 3603), Madrid, Madrid, Comunidad De, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 3607), Madrid, Madrid, Comunidad De, Spain
Hospital Universitario La Paz-Oncología Médica ( Site 3604), Madrid, Madrid, Comunidad De, Spain
Fundación Instituto Valenciano de Oncología-Oncologico ( Site 3605), Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 3602), Barcelona, , Spain
Karolinska Universitetssjukhuset Solna ( Site 3701), Stockholm, Stockholms Lan, Sweden
Kantonsspital Graubünden-Medizin ( Site 3803), Chur, Grisons, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 3802), Bellinzona, Ticino, Switzerland
Inselspital Bern-Oncology ( Site 3801), Berne, , Switzerland
ROYAL MARSDEN HOSPITAL (CHELSEA)-Gynaecology Research Centre ( Site 4002), London, England, United Kingdom
The Royal Cornwall Hospital ( Site 4009), Truro, England, United Kingdom
University College London Hospital-Cancer Clinical Trials Unit ( Site 4004), London, London, City Of, United Kingdom
Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 4010), London, Sutton, United Kingdom
The Christie NHS Foundation Trust-Medical Oncology ( Site 4003), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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